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National Evidence-Based Guideline
Prevention, Identification
and Management of
Foot Complications
in Diabetes
These guidelines have been endorsed by | Australasian Podiatry Council | Australian Diabetes Educators Association
Australian Diabetes Society | Australian Practice Nurses Association | Diabetes Australia Ltd
Pharmaceutical Society of Australia | The Royal Australian College of General Practitioners
N
April 2011
© Commonwealth of Australia 2011
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Disclaimer
This document is a general guide to appropriate practice, to be followed subject to the circumstances, clinician’s judgement
and patient’s preferences in each individual case. The guidelines are designed to provide information to assist decision making.
Recommendations contained herein are based upon the best available evidence published up to 1 November 2009 through to
10 December 2009 for the last question searched. The relevance and appropriateness of the information and recommendations
in this document depend on the individual circumstances. Moreover, the recommendations and guidelines are subject to change
over time. Copies of the guideline can be downloaded through the Baker IDI Heart & Diabetes website: www.bakeridi.edu.au or
the Type 2 diabetes guideline website: http://t2dgr.bakeridi.edu.au
Each of the parties involved in developing this document expressly disclaims and accepts no responsibility for an undesirable
consequences arising from relying on the information or recommendations contained herein.
Funding
Baker IDI Heart and Diabetes Institute, The George Institute for Global Health and Adelaide Health Technology Assessment
(The University of Adelaide) acknowledges the financial assistance provided by the Australian Government Department of
Health and Ageing. The development of the final recommendations has not been influenced by the views or interests of the
funding body.
Suggested citation
National Evidence-Based Guideline on Prevention, Identification and Management of Foot Complications in Diabetes (Part of
the Guidelines on Management of Type 2 Diabetes) 2011. Melbourne Australia
For further information
Baker IDI, Level 3, 193-195 North Terrace, Adelaide, South Australia 5000, Australia
Telephone: +61 (0)8 8462 9700 | Facsimile: +61 (0)8 8232 4044 | Email: [email protected]
Publication approval
These guidelines were approved by the Chief Executive Officer of the National Health and Medical Research Council (NHMRC)
on 6 April 2011, under Section 14A of the National Health and Medical Research Council Act 1992. In approving these
guidelines the NHMRC considers that they meet the NHMRC standard for clinical practice guidelines. This approval is valid for a
period of 5 years.
NHMRC is satisfied that they are based on the systematic identification and synthesis of the best available scientific evidence
and make clear recommendations for health professionals practising in an Australian health care setting. The NHMRC expects
that all guidelines will be reviewed no less than once every five years.
This publication reflects the views of the authors and not necessarily the views of the Australian Government.
2
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
Contents
Summary of Evidence-Based Recommendations and Expert Opinions
Recommendations and Expert Opinions Relevant to Primary Care Settings
5
Management of Foot Complications in Primary Care Settings
6
Recommendations and Expert Opinions Relevant to Specialist Settings
7
Project Outline
8
Scope and Purpose of the Guideline
8
Structure of the Guideline
9
Guideline Development Process and Life of the Guideline
9
Grading Method
10
Technical Report
12
Part A: Overview
13
A1 Foot Complications in Diabetes – Rationale for a National
Evidence-Based Guideline
13
A2 Epidemiology of Foot Complications in Diabetes
13
A3 Economic Consequences of Foot Complications in Diabetes
14
A4 Cost Effectiveness of Assessment, Prevention and Management
of Foot Complications
14
A5 Aboriginal and Torres Strait Islander people and Diabetic Foot Complications
15
A6 Access to Care and Education
15
A7 Clinical Questions for the Systematic Literature Review and
Background Questions
16
Part B: Assessments for Foot Complications in Diabetes
17
Assessing Risk of Developing Foot Complications
17
Identifying Those at Risk of Foot Complications
18
Defining Risk of Foot Complications and Amputation
19
Frequency of Risk Assessment
20
Part C: Prevention of Foot Complications in Diabetes
21
Foot Protection Program
21
Therapeutic Footwear
21
Educational Programs
21
Cost-Effectiveness of Prevention Strategies
22
Part D: Management of Foot Complications in Diabetes
23
D1 Treatment of Diabetes-Related Foot Ulceration in Primary Care Settings
23
D2 Treatment of Diabetic Foot Ulceration in Specialist Settings
30
D3 Monitoring of Response to Treatment and Prevention of Ulcer Recurrence
33
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
5
3
4
Part E: Future Research
34
Part F: Implementation
35
Introduction
35
Relationship of the Guideline to Current Practice
35
An Approach to Implementation
35
Integration of the Guideline into Daily Practice
36
Access and Resourcing
36
Awareness, Education and Training
37
Part G: Related International Guidelines and Resources
38
Appendix 1: Grading Foot Ulcer Severity – Additional Tools
39
Appendix 2: Charcot’s Neuroarthropathy
42
Appendix 3: Foot Expert Panel
45
Appendix 4: Project Executive
47
Appendix 5: Guidelines Advisory Committee
48
Appendix 6: Glossary of Acronyms/Terms
49
Appendix 7: References
50
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
Summary of Evidence-Based
Recommendations and Expert Opinions
EBR
Evidence-based recommendation formulated after a systematic review of the literature
EO
Expert opinion – where evidence was absent or unreliable and advice was formulated
based on the clinical judgement and experience of experts in the field
Recommendations and Expert Opinions Relevant to Primary Care Settings
Assessing and defining risk
EBR 1
Assess all people with diabetes and stratify their risk of
developing foot complications.1
Grade C
p19
EO 1
Any suitably trained healthcare professional may perform the risk
assessment.
EO
p19
EBR 2
Assess risk stratification by inquiring about previous foot
ulceration and amputation, visually inspecting the feet
for structural abnormalities and ulceration, assessing for
neuropathy using either the Neuropathy Disability Score or a
10g monofilament and palpating foot pulses.1
Grade C
p19
EBR 3
Stratify foot risk in the following manner:
Grade C
p19
EO
p19
EO 2
•
“low risk”- people with no risk factors and no previous history of
foot ulcer/amputation
•
“intermediate risk”- people with one risk factor (neuropathy,
peripheral arterial disease or foot deformity) and no previous
history of foot ulcer/amputation
•
“high risk” - people with two or more risk factors (neuropathy,
peripheral arterial disease or foot deformity) and/or a previous
history of foot ulcer/amputation1
Until adequately assessed all Aboriginal and Torres Strait
Islander people with diabetes are considered to be at high risk
of developing foot complications and therefore will require foot
checks at every clinical encounter and active follow-up.
Frequency of risk assessment
EO 3
In people stratified as having low-risk feet (where no risk
factors or previous foot complications have been identified), foot
examination should occur annually.
EO
p20
EO 4
In people stratified as having intermediate-risk or high-risk feet EO
(without current foot ulceration), foot examination should occur at
least every 3 to 6 months.
p20
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
5
Prevention of foot complications
EBR 4
People assessed as having “intermediate risk” or “high
risk” feet should be offered a foot protection program. A foot
protection program includes foot care education, podiatry review
and appropriate footwear.1
Grade C
p22
EO 5
Podiatry review is an important component of a foot protection
EO
program. However, in settings where this is not possible, a suitably
trained health care worker may undertake a review of the feet.
p22
EO 6
Foot care education should be provided to all people with
diabetes to assist with prevention of foot complications.
EO
p22
EO
p23
Grade C
p24
Management of Foot Complications in Primary Care Settings
Predicting outcomes from foot ulcer
EO 7
A foot ulcer is serious and needs to be managed immediately.
Tools for grading of foot ulcer severity
EBR 5
Foot ulcer severity can be graded on the basis of wound depth,
presence of infection (local, systemic or bone) and presence of
peripheral arterial disease. Ulcer grading helps determine the
degree of risk to the person and limb.2,3 The University of Texas
(UT) wound classification system is the most useful tool for
grading foot ulcers.4,5
Interventions for ulcer management
Wound debridement
EO 8
Local sharp debridement of non-ischaemic wounds should be
performed as it improves ulcer healing.
EO
p26
EBR 6
Topical hydrogel dressings may be considered for autolytic
debridement to assist the management of non-ischaemic, nonhealing ulcers with dry, non-viable tissue.6-9
Grade B
p26
EO
p26
Wound dressings and other topical treatments
EO 9
6
There is insufficient evidence to demonstrate the superiority of
any one wound dressing over another in management of ulcers.
This means that the dressing plan will need to be tailored to the
specific characteristics of the wound. In non-ischaemic ulcers,
create a moist wound environment. In ischaemic ulcers maintain
a dry wound environment using a dry, non-adherent dressing, until
the wound has been reviewed by someone with experience in
peripheral arterial disease.
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
Pressure reduction, redistribution of pressure or offloading of the wound
EBR 7
Pressure reduction, otherwise referred to as redistribution of
pressure or offloading, is required to optimise the healing of
plantar foot ulcers.10
Grade B
p27
EBR 8
Offloading of the wound can be achieved with the use of a total
contact cast or other device rendered irremovable.10
Grade B
p27
EO 10
Other removable offloading devices may be considered
in particular settings (e.g. wounds that require more regular
debridement and dressing changes) or where patient factors
(e.g. significant risk of falls) do not allow the use of an
irremovable device.
EO
p27
Types of care
EBR 9
People with diabetes-related foot ulceration are best managed by
a multi-disciplinary foot care team11-14
Grade C
p28
EO 11
The following factors should always precipitate referral to a multidisciplinary foot care team:
EO
p28
Grade C
p28
•
deep ulcers (probe to tendon, joint or bone)
•
ulcers not reducing in size after 4 weeks despite
appropriate treatment
•
the absence of foot pulses
•
ascending cellulitis and
•
suspected Charcot’s neuroarthropathy (e.g. unilateral, red, hot,
swollen, possibly aching foot)
If access to a multi-disciplinary foot care team is limited, foot
ulceration or foot complications other than those above should
be managed by a GP together with a podiatrist and/or wound
care nurse.
EBR 10
Remote expert consultation with digital imaging should be
made available to people with diabetic foot ulceration living in
remote areas who are unable to attend a multi-disciplinary foot
care team/service for management.15
Recommendations and Expert Opinions Relevant to Specialist Settings
Management in specialist settings
The following may be considered for foot ulcers in specialist centres, as part of a comprehensive
wound management program:
EBR 11
EBR 12
Topical negative pressure therapy16-22
Hyperbaric oxygen therapy
23-30
31-33
EBR 13
Larval therapy
EBR 14
Skin replacement therapies
•
Cultured skin equivalents
•
Skin grafting44
Grade B
p30
Grade B
p30
Grade C
p31
p31
34-43
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
Grade B
Grade D
7
Project Outline
Scope and Purpose of the Guideline
This guideline is part of an overall set of recommendations for the prevention, diagnosis and
management of type 2 diabetes. The other components of the type 2 diabetes guidelines include:
• Primary Prevention
• Case Detection and Diagnosis
• Patient Education
• Blood Glucose Control
• Diagnosis, Prevention, and Management of Chronic Kidney Disease
• Management of Diabetic Retinopathy
• Blood Pressure and Control
• Lipid Control
• Prevention and Detection of Macrovascular Disease
A guideline on primary prevention of vascular disease for people with and without diabetes is also
currently being completed by the National Vascular Disease Prevention Alliance (NVDPA).
This national evidence-based guideline addresses: Prevention, identification and management of
foot complications in diabetes, and is equally relevant for type 1 and type 2 diabetes.
This guideline will update and replace the section of the national evidence-based guidelines for the
management of type 2 diabetes mellitus, namely: Part 6 detection and prevention of foot problems in
type 2 diabetes (last updated 2005).
The purpose of this guideline is to inform a broad range of health professionals and health care
workers of best practice to prevent, identify and manage foot complications in adults with type 1 or 2
diabetes in both urban and rural/remote primary care and in specialist foot centres.
The scope of this revised guideline was primarily driven by the scope of the original guideline (2005)
with adjustments made by the panel of experts drawn together to assess the recent evidence. There is
one notable gap in the previous and current version of the guideline; recommendations or information
on assessment and management of osteomyelitis. The expert panel recognises the need for a
systematic examination of this area in the next revision of the guideline.
The recommendations and expert opinion-based statements in this guideline apply equally to
Aboriginal and Torres Strait Islander people and non-Indigenous Australians. Specific guidance,
however, has been provided in regard to the frequency of screening for foot complications for
Aboriginal and Torres Strait Islander people. Further, special consideration has been given to
targeting this high risk population in the implementation plan for this guideline. Education, services
and programs for people with particular needs will need to be delivered in culturally appropriate and
sensitive ways.
8
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
Structure of the Guideline
Clinical questions† were developed by a panel of foot experts (see Appendix 3) and used to structure
the guideline into the following parts:
Part A gives a general overview of foot complications in diabetes, including a discussion of
foot problems in the context of type 1 and 2 diabetes, the significance of this problem, and key
issues in diagnosing and treating people with foot complications
Part B reviews the evidence in relation to assessment of risk of developing foot complications
and assessment of severity of foot ulcers
Part C discusses prevention of foot complications from diabetes
Part D summarises the evidence for healing of foot ulcers and management of foot
complications in relation to therapeutic and educational interventions, as well as to organisation
of care
Part E discusses future research and development
Part F discusses implementation
Appendices provide additional information and resources on Charcot’s neuroarthropathy and
provide detail of the team that prepared the guideline.
Guideline Development Process and Life of the Guideline
Baker IDI Heart and Diabetes Institute, The George Institute for Global Health and Adelaide Health
Technology Assessment convened an expert panel and guidelines advisory committee (GAC) in
2009 to review the 2005 national evidence-based guideline for the management of type 2 diabetes
mellitus, Part 6 detection and prevention of foot problems in type 2 diabetes. The process involved
reviewing and rewriting the original questions. From the questions a protocol was developed that
guided the systematic literature review. Searches for evidence were conducted in relevant databases,
bibliographies of identified relevant studies, guidelines and websites of relevant peak bodies between
1 November 2009 and 10 December 2009. The Foot Expert Panel and GAC meet regularly throughout
2009/2010 to review and approve the questions, protocol and drafted recommendations/guideline.
The drafted guideline then underwent a 30 day consultation period.
A list of committee members, expert panel members and the project executive are outlined in
Appendix 3, 4 and 5. Their declaration of competing interests can be found at
http://t2dgr.bakeridi.edu.au under the conflict of interest quick links.
This guideline should be fully reviewed within 5 years from date of release; however the guideline
developers strongly recommend annual re-running of the literature searches to identify new evidence
for consideration as to whether the recommendations or expert opinions should be revised.
The guideline developers also strongly recommend that a systematic review of the literature on
assessment and management of osteomyelitis should be undertaken during a future revision of
the guideline.
† All clinical questions and methodological detail in the accompanying technical report
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
9
Grading Method
Each recommendation was formulated using evidence-based methods and graded using the NHMRC
grades of recommendations.
Definition of NHMRC grades of recommendations45
Grade of recommendation Description
A
Body of evidence can be trusted to guide practice
B
Body of evidence can be trusted to guide practice in most situations
C
Body of evidence provides some support for recommendation(s) but
care should be taken in its application
D
Body of evidence is weak and recommendation must be applied
with caution
To develop these graded recommendations, the body of evidence addressing each of the clinical
questions was rated according to the criteria outlined in Table 1, using an Evidence Statement Form
(ESF). This allows explicit and transparent formulation of the recommendation on the basis of the
available evidence.
When the evidence was of sufficient strength (generally Grade C or above), applicable to the
Australian context, consistent with usual practice and/or with positive cost effectiveness data, the
expert panel formulated an evidence-based recommendation. The recommendations operationalised
the evidence-based statements which were developed as part of the systematic review process.
These evidence-based recommendations are designed to be practical, clear and action-oriented in
order to assist with clinical decision making. Evidence-based recommendations are identified in the
text by the use of the acronym EBR.
Expert Opinion (EO) is a consensus statement from experts to inform clinical practice. These are
provided to guide clinical practice in the following circumstances:
•
where evidence is of poor quality and not considered reliable enough for an evidence-based
recommendation to be formulated;
•
in the absence of evidence that directly answers the clinical question (evidence gaps found through
the systematic literature review); and/or
•
to supplement a graded recommendation by providing suggestions as to how the recommendation
may be implemented in clinical practice.
Expert opinions were initially formulated by the Foot Expert Panel, ratified by the Guideline Advisory
Committee and then an online survey was conducted to determine wider expert agreement with
the statements.
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National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
Table 1 Components of body of evidence considered when grading each recommendation45
Component
A
B
C
D
Excellent
Good
Satisfactory
Poor
one or more level
I studies with a
low risk of bias
or several level II
studies with a low
risk of bias
one or two level II
studies with a low
risk of bias or a
SR/several level
III studies with a
low risk of bias
one or two level
III studies with a
low risk of bias, or
level I or II studies
with a moderate
risk of bias
level IV studies,
or level I to III
studies/SRs with a
high risk of bias
Consistency§
all studies
consistent
most studies
consistent and
inconsistency may
be explained
some
evidence is
inconsistency
inconsistent
reflecting genuine
uncertainty around
clinical question
Clinical impact
very large
substantial
moderate
slight or restricted
Generalisability
population/s
studied in body of
evidence are the
same as the target
population for the
guideline
population/s
studied in the
body of evidence
are similar to the
target population
for the guideline
population/s
studied in body of
evidence differ to
target population
for guideline but
it is clinically
sensible to apply
this evidence to
target population¶
population/s
studied in body of
evidence differ to
target population
and hard to
judge whether
it is sensible to
generalise to
target population
Applicability
directly applicable applicable to
to Australian
Australian
healthcare context healthcare context
with few caveats
Evidence base
†‡
not applicable
probably
to Australian
applicable to
healthcare context
Australian
healthcare context
with some caveats
SR = systematic review; several = more than two studies † ‡ §¶
† Level of evidence determined from the NHMRC evidence hierarchy – see Table 2
‡ Risk of bias was defined by the quality of the individual study. A rating of low, moderate or high risk of bias was assigned to
studies of high, average and low quality, respectively.
§ If there is only one study, rank this component as ‘not applicable’
¶ For example, results in adults that are clinically sensible to apply to children OR psychosocial outcomes for one cancer that
may be applicable to patients with another cancer.
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
11
Table 2 NHMRC levels of evidence45,46
Level
Intervention
Diagnostic Accuracy
Prognosis
I
A systematic review of level
II studies
A systematic review of level
II studies
II
A randomised controlled trial
A study of test accuracy with: A prospective cohort study
an independent, blinded
comparison with a valid
reference standard, among
consecutive persons with a
defined clinical presentation
III-1
A pseudorandomised
controlled trial
(i.e. alternate allocation or
some other method)
A study of test accuracy with: All or none
an independent, blinded
comparison with a valid
reference standard, among
non-consecutive persons
with a defined clinical
presentation
III-2
A comparative study with
concurrent controls:
A comparison with reference
standard that does not meet
the criteria required for Level
II and III-1 evidence
Analysis of prognostic
factors amongst persons in a
single arm of a randomised
controlled trial
Diagnostic case-control
study
A retrospective cohort study
III-3
IV
•
Non-randomised,
experimental trial
•
Cohort study
•
Case-control study
•
Interrupted time series
with a control group
A comparative study without
concurrent controls:
•
Historical control study
•
Two or more single arm
•
Interrupted time series
without a parallel control
group
Case series with either
Study of diagnostic yield (no
post-test or pre-test/post-test reference standard)
outcomes
A systematic review of level
II studies
Case series, or cohort study
of persons at different stages
of disease
Technical Report
The full findings of the systematic literature review are available at http://t2dgr.bakeridi.edu.au/
12
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
Part A: Overview
This part of the guideline gives a general overview of foot complications in diabetes, based on recent
review articles, international guidelines and information from Australian surveys and data collections.
A1 Foot Complications in Diabetes – Rationale for a National EvidenceBased Guideline
To date, considerable effort and research has been directed towards primary prevention of foot
complications in patients with diabetes. In 1998, the National Diabetes Strategy47 identified foot care
as a major issue and recommended implementation of a National Diabetic Foot Disease Management
Program. The aims of the program included a 50% reduction in lower limb amputation by 2005 and
an 80% level of screening for risk factors for diabetes-related foot complications each year. However,
for this to be achieved, health professionals require knowledge and resources that enable them to
appropriately identify those at risk and to implement strategies to prevent adverse outcomes.
In Australia the prevalence of type 2 diabetes has increased dramatically over the past two decades
and continues to rise, with a current prevalence of approximately 7%.48 This translates to an everincreasing population of people who are at risk of developing foot complications. It is estimated that
15% of people with diabetes will develop a foot ulcer during their lifetime.
The spectrum of diabetes-related complications that affect the foot includes ulceration, deformity,
ischaemia, infection (including osteomyelitis), and Charcot’s neuroarthropathy (CNA)†. The
pathophysiology of foot ulceration is complex and multi-factorial. Peripheral neuropathy, peripheral
arterial disease, foot deformity, trauma, infection, impaired healing and limited self-care may all
contribute to foot ulceration or failure of healing of ulceration. Failure of foot ulcers to heal can lead
to amputation.
A2 Epidemiology of Foot Complications in Diabetes
Peripheral neuropathy, foot deformity, external trauma, peripheral arterial disease and peripheral
oedema are all common causes of foot ulceration with the first three listed identified as being the
most common.49 A study by Tapp et al found that in a population-based sample of Australian adults
aged 25 years or older (the Australian Diabetes, Obesity, and Lifestyle Study) the prevalence of
peripheral neuropathy was 13.1% in those with previously diagnosed diabetes and 7.1% in those with
newly diagnosed diabetes.50 The prevalence of peripheral arterial disease (PAD) was 13.9% in those
with previously diagnosed diabetes and 6.9% in those with newly diagnosed diabetes. A substantial
proportion of people with diabetes (19.6%) were at risk of foot ulceration.
Foot ulceration is a leading cause of hospitalisation for people with diabetes. The Australian
Institute of Health and Welfare (AIHW) reports that diabetes-related foot ulceration resulted in 9,900
hospitalisations for years 2004-2005.51
In Australia, diabetes is acknowledged to be the most common cause of non-traumatic lower-limb
amputation.52 In 2000 the incidence of lower limb amputation in people with diabetes was estimated at
0.8% per year53 with recent reports suggesting this rate to be increasing. In 2004-2005, approximately
† Charcot’s neuroarthropathy is considered an important complication for people with diabetes, however, it fell outside of the
scope of the systematic literature review for this guideline. In light of its clinical importance, material has been developed
from key literature as a reference for health professionals. See Appendix 2.
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
13
3,400 diabetes-related lower limb amputations were reported by the Australian Institute of Health and
Welfare51 as compared to approximately 2,600 for each year between 1995 and 1998.
Of all lower limb amputations, about half are classified as major (below or above knee) while the
other half are classified as minor (distal to the ankle). Of those who have an amputation, about half
will experience a subsequent amputation of the other limb.54 Five-year survival for those who have
had limb amputation is poor, with mortality rates ranging from 39 to 80%.55 Diabetes related foot
complications are more prevalent in the elderly, which suggests a further increase in this condition as
the population ages and diabetes prevalence increases.
A3 Economic Consequences of Foot Complications in Diabetes
In Australia in 2004-2005, the average length of hospital stay for people with diabetes requiring lower
limb amputations was 26 days.51
A recent study estimated the cost of lower extremity amputations in Australia to be $A26,700 per
person. Estimated costs for other countries were $A24,660 for Canada; $A46,064 for France;
$A31,809 for Germany; $A14,650 for Italy; and $A21,287 for Spain.56 Other direct and indirect
economic costs of foot complications, not included in the above data, include the costs of
rehabilitation, purchase and fitting of orthotics/prostheses, and time lost from work.
A4 Cost Effectiveness of Assessment, Prevention and Management of
Foot Complications
A number of cost-effectiveness systematic reviews57,58 or health economic evaluations of a variety of
strategies for the prevention, diagnosis and management of foot complications in people with diabetes
have been conducted.
Those strategies determined to be cost-effective or have cost-utility (and possibly be cost
saving) include:
• Preventative strategies such as prevention programs, optimal foot care, regular foot examinations,
intense glycaemic control and patient education
• Proper management and early institution of antibacterial therapy
• MRI for diagnosing osteomyelitis in patients with diabetic foot ulcers (but at higher cost)
• Novel therapies such as bio-engineered live skin equivalents and hyperbaric oxygen
therapy (HBOT)
None of these evaluations considered the Australian context and some had methodological issues
such that some of the results may be overstated and need to be interpreted with caution. The authors
of the studies conclude that more quality economic studies are needed in this area, and need to
consider appropriate sample sizes with adequate power, study design, study duration, blinding of
outcome assessors and appropriate selection of endpoints and outcomes.
These promising cost-effectiveness analyses from other countries provide ample justification for
similar analyses that consider Australian data and resource use.
Many individual drugs and some MBS funded procedures will already have been assessed in terms
of their cost effectiveness in Australia. However, strategies that involve team care and a range of
procedures are not routinely assessed for cost effectiveness.
14
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
A5 Aboriginal and Torres Strait Islander people and Diabetic Foot Complications
In 2006 it was reported that Aboriginal and Torres Strait Islander people were more than three times
as likely to have diabetes as non-Indigenous Australians. Aboriginal and Torres Strait Islander people
living in remote areas are more likely to have diabetes than those living in non-remote areas.
The prevalence of diabetes amongst Aboriginal and Torres Strait Islander people over 55 years
of age is over 30%.59 McDermott et al reported the incidence of diabetes in remote community
Aboriginal and Torres Strait Islander populations in far north Queensland to be nearly 4 times higher
than the non-indigenous populations and 50% higher than the incidence reported 10 years ago in
Australian Aboriginals.60
Diabetes-related foot complications are also prevalent in Aboriginal and Torres Strait Islander people.
Aboriginal and Torres Strait Islander people also experience the greatest risk of amputation. Trends in
amputations for arterial disease or diabetes-related complications in Western Australia for the period
2000-2008 show that among those aged 25-49 with diabetes, minor amputations were 27 times more
likely, and major amputations 38 times more likely, in Aboriginal and Torres Strait Islander people than
in non-indigenous Australians. Nearly all (98%) amputations were related to diabetes.61
A6 Access to Care and Education
The Fremantle Diabetes Study found that “subjects who were older, whose schooling was limited, who
were not fluent in English and/or who were from Southern European or Indigenous Australian ethnic
groups had significantly lower knowledge (of diabetes) scores and were less likely to have received
diabetes education, dietetic advice or to perform self monitoring of blood glucose (SMBG)”.62 The
authors concluded that these populations experienced barriers to access or utilisation of contemporary
diabetes education and were likely to benefit from specialised programs.
Culturally sensitive diabetes education for Indigenous people in North America has been associated
with better outcomes.63,64 Long-term studies in Nauru have demonstrated the importance of education
and health promotion for reducing the incidence of amputation (50% reduction in the incidence of
first lower extremity amputations).65 Such strategies are also likely to improve the foot outcomes of
Aboriginal and Torres Strait Islander populations.
The issue of access to services can be experienced in remote, regional and some urban areas by both
Aboriginal and Torres Strait Islander people and non-Indigenous people with diabetes.
Aboriginal and Torres Strait Islander people, and those from other disadvantaged groups
require particular attention in regard to screening, early intervention and monitoring to improve
clinical outcomes.
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
15
A7 Clinical Questions for the Systematic Literature Review and
Background Questions
The following clinical questions were used to conduct a systematic review of the literature:
Question
Number
Questions
EBR or Expert
Opinion number
Assessment
1
Which assessments lead to improved foot-related clinical
outcomes in people with diabetes?
EBR 1 - 4, EO 1 and
EO 2
2
Which clinical assessments best predict foot ulcer and/
or amputation in people with diabetes? (In the absence of
evidence for Q1, this question would then be answered)
See Question 1
above.
3
Which assessments best predict foot ulcer severity and
outcomes in people with foot ulcer? (In the absence of
evidence for Q1, this question would then be answered)
4
How often, and by whom, should foot assessments be
carried out in people with or without foot ulcer?
EO 3-5
5
When should a patient be referred to a high risk foot clinic?
(What are the risk factors for a poor foot related outcome for
people in a primary care setting?)
EO 11
Which interventions improve foot related clinical outcomes –
EBR 6-14, EO 6,
EO 8-10
EBR 5, EO 7
Intervention
6
a) For people without foot ulceration?
b) For people with foot ulcer?
7
Under what circumstances are antibiotics effective in the
treatment of foot ulceration?
No recommendation
See Section D1
Background questions†
Question Number
Questions
Location
Assessment
Background Question 1
What clinical signs indicate the presence of Charcot
neuroarthropathy?
See Appendix 2
Response to Treatment
Background Question 2
How is the effectiveness of interventions for
ulceration monitored?
Section D3
Background Question 3
What are the economic consequences of diabetes
foot problems?
Section A3
Background Question 4
What are the socioeconomic factors associated with
diabetes foot problems?
Economics
Section A5-6
† Background questions were still the subject of a literature review, but not a systematic review
16
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of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
Part B: Assessments for Foot
Complications in Diabetes
This part of the guideline describes the clinical assessments for foot complications in diabetes.
Part B provides evidence from the systematic literature review and details recommendations and
expert opinions (in the absence of evidence) on the following:
• upstream causes and risk factors for foot complications;
• tools for identifying and defining risks of foot complications and amputation; and
• the frequency of monitoring for foot complications in diabetes.
Assessing Risk of Developing Foot Complications
Risk factors
Preventing foot complications begins with identifying those at risk. The risk of foot ulceration and
amputation is increased in patients with the following four risk factors:
• Previous Foot Ulceration or Previous Amputation
• Peripheral Neuropathy
• Peripheral neuropathy can be easily identified using ordinary bedside clinical tools. The best
evidence for identifying the risk of neuropathic ulceration supports use of the 10g monofilament
or the Neuropathy Disability Score (NDS). The NDS is a score based on vibration perception,
pin-prick sensation, temperature perception, as well as ankle (Achilles) reflexes. It requires the
use of a tuning fork (for both vibration and temperature sensation), neurological pin and tendon
hammer. Refer Box 1 for the NDS ‘score sheet’.
• Peripheral Arterial Disease
• The best clinical guide to the presence of peripheral arterial disease is palpation of foot pulses,
which has been shown to predict foot ulceration and amputation. Although claudication can
be a useful symptom, peripheral arterial disease is commonly asymptomatic in people with
diabetes. The ankle-brachial pressure index (ABPI or ABI), using Doppler ultrasound is a useful
adjunct to assess foot perfusion. The results of this investigation can be falsely elevated in the
presence of arterial calcification in people with diabetes. The toe-brachial pressure index or toe
pressures (using photoplethysmography) are useful adjuncts for assessing foot perfusion if the
ABPI is falsely elevated.
• Foot Deformity
• This includes, but is not limited, to such conditions as: hallux deformity, hammer/claw toe,
callus, previous amputation, excessively flat or high arched feet, abnormally wide feet and
Charcot’s neuroarthropathy.
Box 2 provides an overview of the tools for assessing neuropathy, circulation and foot deformity.
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
17
There is also evidence to suggest that the following factors increase risk of foot complications:
• visual impairment
• kidney disease
• poor glycaemic control
• ill-fitting footwear
• socio-economic disadvantage
Whilst the presence of peripheral neuropathy is the leading risk factor for foot ulceration, a pivotal
event, such as trauma from footwear, is also needed for most ulcers to occur.66 Rubbing from footwear
was identified as the definite cause of 35% of foot ulcers reviewed as part of a prospective study
conducted in the United Kingdom.67 Furthermore, the follow-up of 472 patients at The Royal Prince
Alfred Hospital Diabetes Centre (NSW, Australia) identified that 50% of all foot ulcers that developed in
this group, could be directly attributed to trauma from footwear.68
Box 1
Modified Neuropathy Disability Score69
Neuropathy Disability Score (NDS)
Right
Left
Vibration Perception Threshold
128-Hz tuning fork; apex of big toe:
normal = can distinguish vibrating/
not vibrating
Normal = 0
Abnormal = 1
Temperature perception on
Dorsum of the Foot
Use tuning fork with beaker of ice/
warm water
Pin Prick
Apply pin proximally to big toe nail
just enough to deform the skin;
Trial pair: sharp, blunt;
Normal= can distinguish sharp/
not sharp
Achilles Reflex
Present = 0
Present with reinforcement = 1
Absent = 2
NDS Total out of 10
Identifying Those at Risk of Foot Complications
One large randomised trial examined the effects of a 2-stage foot screening program followed by
a foot protection program for those classified as high risk for foot ulceration compared to standard
care. Patients randomised to screening were classified as high or low risk for foot ulceration. Those
classified as high risk were entered into a foot protection program that included foot care (podiatry and
hygiene maintenance), support hosiery and protective shoes. Those classified as low risk received no
18
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
further special treatment. A significant reduction in major and total amputation was demonstrated in the
intervention group and there was a trend to increased ulcer healing†.1
The foot screening program was also shown to be cost-effective in a UK setting.1 Taking into
account the cost of the screening and protection program, and comparing it to the cost of an avoided
amputation, a net cost saving was calculated for the amputations prevented out of the 1,001 patients
in the intervention arm of the study.
Other, non-randomised, observational studies have shown that a range of other commonly used
clinical assessments (see Box 2) are effective in predicting foot ulceration and/or amputation.70-72
These single assessments and combined assessments are outlined in more detail in the technical
report. The combined assessment within the Neuropathy Disability Score (NDS) appeared to perform
better at predicting foot ulceration and lower extremity amputation than did single assessments but no
direct comparison has been reported.
EBR 1
Assess all people with diabetes and stratify their risk of developing
foot complications.1
Grade C
EO 1
Any suitably trained healthcare professional may perform the risk
assessment.
EO
EBR 2
Assess risk stratification by inquiring about previous foot ulceration
Grade C
and amputation, visually inspecting the feet for structural abnormalities
and ulceration, assessing for neuropathy using either the Neuropathy
Disability Score or a 10g monofilament and palpating foot pulses.1
Defining Risk of Foot Complications and Amputation
EBR 3
EO 2
Stratify foot risk in the following manner:
•
“low risk”- people with no risk factors and no previous history of foot
ulcer/amputation
•
“intermediate risk”- people with one risk factor (neuropathy, peripheral
arterial disease or foot deformity) and no previous history of foot ulcer/
amputation
•
“high risk” - people with two or more risk factors (neuropathy,
peripheral arterial disease or foot deformity) and/or a previous history
of foot ulcer/amputation1
Grade C
Until adequately assessed all Aboriginal and Torres Strait Islander
EO
people with diabetes are considered to be at high risk of developing foot
complications and therefore will require foot checks at every clinical
encounter and active follow-up.
† Refer technical report, Question 1, Table 2 for information on number needed to treat
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
19
Frequency of Risk Assessment
There were no studies providing evidence for the optimal frequency of foot assessment in people with
and without foot ulceration. Expert opinion therefore suggests the following frequencies.
EO 3
In people stratified as having low-risk feet (where no risk factors or
previous foot complications have been identified), foot examination
should occur annually.
EO
EO 4
In people stratified as having intermediate-risk or high-risk feet
(without current foot ulceration), foot examination should occur at least
every 3 to 6 months.
EO
The main aim of the more frequent assessment of those at intermediate or high risk is to reassess for
new risk factors and for other more rapidly-developing problems, such as tinea, gangrene, ulcers, and
Charcot’s neuroarthropathy, which may need immediate intervention.
Box 2
Tools for assessing neuropathy, circulation and foot deformity70-72
• Neuropathy
- 10g monofilament sensitivity
- Vibration perception (tuning fork or biothesiometer)
- Neuropathy Disability Score – ankle (Achilles) reflexes and the sensory
modalities of pinprick, vibration and temperature perception
• Circulation
- Palpation of peripheral pulses
- Ankle-brachial pressure index (ABPI)
- Toe-brachial pressure index
• Foot Deformity Score
6 point scale (1 point for each characteristic)
- small muscle wasting
- Charcot foot deformity
- bony prominence
- prominent metatarsal heads
- hammer or claw toes
- limited joint mobility
Score of 3 or above indicates foot deformity
20
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
Part C: Prevention of Foot
Complications in Diabetes
A number of interventions have been studied for their ability to prevent foot complications.
Foot Protection Program
One large, good quality trial examined the effectiveness of a foot protection program for people with
intermediate to high risk feet (see below for definition).1 A significant reduction in major and total
amputation was demonstrated.
Foot Protection Program1
A Foot Protection Program aims to prevent foot complications in people with
diabetes, and includes the following components:
• Podiatry;
• Hygiene maintenance – advice to inspect and wash feet daily;
• Appropriate footwear and hosiery;
• Protective shoes – avoid constrictive footwear; and
• Clinic contact initiated by patient if concerned.
Therapeutic Footwear
There was insufficient evidence to determine the effectiveness of therapeutic footwear (2 average
quality trials) for the prevention of foot complications. The trials demonstrated a trend towards benefit
of therapeutic footwear with cork or prefabricated insoles over usual footwear. One other small trial
also studied the effects of rigid orthotic devices on plantar callus formation. A significant improvement
in the grade of callus was demonstrated.
Educational Programs
The evidence for educational programmes for the prevention of ulcer recurrence and amputation
was equivocal. Two trials (one good and one average quality) compared brief education with usual
care for the prevention of ulcer recurrence and amputation. One indicated no effect73 and the other
indicated a large positive effect.74 One trial and one controlled study (both average quality) compared
an education program consisting of multiple sessions with usual care for the prevention of foot
complications. The randomised trial indicated no effect on the incidence of foot lesions or requirement
for hospitalisation. The study indicated less callus, mycosis and fissures with the education program.
One large trial (good quality) compared education targeting the patient and doctor with usual care
for the prevention of foot complications and reported a significant reduction in serious foot lesions,
ingrown toenails and dry or cracked skin. No significant reduction in amputation was demonstrated.75
One large trial (average quality) compared home education to usual care for the prevention of
foot complications and reported no effect on foot appearance or hospitalisation rates.76 Two trials
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
21
(average quality) compared intensive education involving one-on-one teaching by a podiatrist with
brief education for the prevention of foot complications. One trial indicated reduced callus after one
year and ingrown toenails after seven years and the other trial indicated a significant reduction
in foot complications during the program, which did not remain after the program had ceased.77,78
A meta-analysis of three trials comparing the addition of any education to usual care alone was also
conducted and found a non- significant reduction in the risk of amputation (refer to the Technical
Report, Figure 15: Meta-analysis of education interventions for the prevention of amputation).
Despite the inconsistent nature of the evidence of educational programmes for prevention of ulcer
recurrence and amputation, foot education was considered by the Expert Panel to be important for
preventing foot complications.
Cost-Effectiveness of Prevention Strategies
There is evidence, from Europe, of cost effectiveness, lower costs and a gain in quality adjusted life
years (QALY’s) in patients receiving optimal foot care alone and those receiving optimal foot care
and intensive glycaemic control together to prevent foot complications.57 In an analysis of prevention
strategies, cost effectiveness was only found when preventive care was provided to people classified
as high risk. Preventive care for low risk patients was not found to be cost effective.
22
EBR 4
People assessed as having “intermediate risk” or “high risk” feet
should be offered a foot protection program. A foot protection program
includes foot care education, podiatry review and appropriate footwear.1
Grade C
EO 5
Podiatry review is an important component of a foot protection program.
However, in settings where this is not possible, a suitably trained health
care worker may undertake a review of the feet.
EO
EO 6
Foot care education should be provided to all people with diabetes to
assist with prevention of foot complications.
EO
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
Part D: Management of Foot
Complications in Diabetes
This part of the guideline discusses the clinical care of foot complications, mostly related to foot
ulceration, in patients with diabetes, in whom early assessment and appropriate intervention are
required to restore optimal functioning, followed by continuing care to prevent recurrence and/or need
for amputation. Early intensive intervention to resolve foot ulcers and other complications in people
with diabetes should be relentlessly pursued to avoid costly future interventions such as amputation
or hospitalisation.
Section D1 provides a summary of current evidence on the treatment of foot ulceration and
management of foot complications in primary care settings from the systematic literature review
undertaken for the guideline, and gives evidence-based recommendations on physical interventions,
pharmacological interventions and combined therapies.
Section D2 provides a summary of current evidence on the treatment of foot ulceration in specialist
settings from the systematic literature review undertaken for the guideline.
Section D3 outlines monitoring of response to treatment and prevention of ulcer recurrence.
D1 Treatment of Diabetes-Related Foot Ulceration in Primary Care Settings
Predicting outcomes from foot ulcer
Foot ulcers can be classified as ischaemic, neuropathic, or neuroischaemic and then further staged or
graded according to a wound classification system. Wound classification systems and other clinical/
laboratory assessments have been studied for their ability to predict foot ulcer severity and outcomes.
A number of clinical or laboratory assessments (Box 3) were found to assist with predicting foot ulcer
outcomes, although the application of many may be restricted to specialist or research centres.
EO 7
A foot ulcer is serious and needs to be managed immediately.
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
EO
23
Box 3
Tools for predicting foot ulcer outcomes
Assessment
Outcome
Transcutaneous oxygen saturation (TcPO2) on
dorsum of foot and toe pressure
TcPO2 >25mmHg and toe pressure >45mmHg
indicating ulcers more likely to improve or heal
X-ray and bone/leukocyte nuclear scans
Presence of osteomyelitis indicating increased
risk of amputation
Ankle peak systolic velocity measurements using
Duplex ultrasound
Low velocities indicating increased risk of ulcer
non-healing
Skin perfusion pressure using a radioisotope
clearance method
Lower skin pressures indicating increased risk of
ulcer non-healing
Capillary perfusion using macro aggregated
albumin scanning
Poor circulation associated with ulcer nonhealing, good circulation associated with ulcer
healing
Hyperspectral imaging of oxyhaemoglobin and
deoxyhaemoglobin
Positive index indicating greater healing than
negative index
Plasma fibrinogen
Fibrinogen >300 mg/dl indicating greater risk of
amputation
Source: Technical report p11-61
Tools for grading of foot ulcer severity
The use of an ulcer grading system and score provides a standardised approach to the documentation
of ulcer severity and assists communication between health care providers.
A number of ulcer grading systems or scores (see Appendix 1) were found to predict foot ulcer healing
and amputation risk. Of these, the University of Texas Wound Grading System and the Wagner Wound
Grade System were considered to have the best discrimination for predicting ulcer healing. When
compared, the University of Texas Wound Grading System was found to be more useful in grading
foot ulcers (see Box 4).
EBR 5
24
Foot ulcer severity can be graded on the basis of wound depth,
Grade C
presence of infection (local, systemic or bone) and presence of peripheral
arterial disease. Ulcer grading helps determine the degree of risk to the
person and limb.2,3 The University of Texas (UT) wound classification
system is the most useful tool for grading foot ulcers.4,5
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
Box 4
University of Texas Wound Grading System5,79
Grade/depth: “How deep is the wound?”
Depth
Stage/
Comorbidities:
“Is the wound
infected,
ischemic, or
both?”
Grade
0
I
II
III
A
Pre- or postulcerative lesion
completely
epithelialized
Superficial
wound not
involving
tendon, capsule
or bone
Wound
penetrating
to tendon or
capsule
Wound
penetrating to
bone or joint
B
Pre- or postulcerative lesion
completely
epithelialized
with infection
Superficial
wound not
involving
tendon, capsule
or bone with
infection
Wound
penetrating
to tendon or
capsule with
infection
Wound
penetrating to
bone or joint
with infection
C
Pre- or postulcerative lesion
completely
epithelialized
with ischemia
Superficial
wound not
involving
tendon, capsule
or bone with
ischemia
Wound
penetrating
to tendon or
capsule with
ischemia
Wound
penetrating to
bone or joint
with ischemia
D
Pre- or postulcerative lesion
completely
epithelialized
with infection
and ischemia
Superficial
wound not
involving
tendon, capsule
or bone with
infection and
ischemia
Wound
penetrating
to tendon or
capsule with
infection and
ischemia
Wound
penetrating to
bone or joint
with infection
and ischemia
Armstrong et al 19985
Interventions for ulcer management
Wound debridement
The first priority of management of foot ulceration is to prepare the surface and edges of a wound
to facilitate healing. If foot pulses are present, non-viable tissue should be removed from the wound
bed and surrounding callus removed. If foot pulses are absent, assessment and management of the
peripheral vasculature is mandatory before removal of non-viable or necrotic tissue is considered.
Referral to a vascular surgeon and/or multidisciplinary team is suggested in this situation.
Removal of non-viable tissue can be quickly and effectively accomplished by local sharp debridement.
Other forms of debridement include mechanical, e.g. the wet to dry method of soaking the wound with
a wet gauze and then removing non-viable tissue that has dried onto it; autolytic, e.g. using hydrogels
that when applied to a dry wound complement the body’s natural debridement process; and sterile
larvae (maggot) therapy.
Evidence on the preferred form, frequency and extent of debridement was reviewed and proved
insufficient to draw any conclusions. One small trial investigated the effectiveness of surgical
debridement that included conic ulcerectomy compared to standard wound care that included local
sharp debridement. Surgical debridement significantly reduced the time to ulcer healing however the
number of ulcers healed was not increased.80 One systematic review (good quality) of three trials (of
varying quality) assessed the use of hydrogels for wound debridement in addition to standard wound
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
25
care compared with standard wound care alone. Hydrogel dressings significantly increased the
number of ulcers healed and were associated with fewer adverse events than standard wound care.7
Clinical experience suggests that local sharp debridement should be considered first followed by
one or more of the other modalities, depending on the clinical presentation or response of a wound.
Debridement should be repeated as often as required to remove all non-viable tissue.
Newer forms of mechanical debridement (e.g. acoustic energy or ultrasonic sound waves and highpressure jet of sterile saline) are increasingly available and popular for use in practice, however there
was no high quality evidence found to support their use.
EO 8
Local sharp debridement of non-ischaemic wounds should be
performed as it improves ulcer healing.
EO
EBR 6
Topical hydrogel dressings may be considered for autolytic
debridement to assist the management of non-ischaemic, non-healing
ulcers with dry, non-viable tissue.6-9
Grade B
Wound dressings and other topical treatments
All foot ulcers require regular inspection, cleansing and dressing. Dressings need to provide a warm
and moist wound environment, absorb excess exudate and protect the wound for optimal healing. The
exception to this being when there is inadequate blood supply to allow wound healing to occur. In this
case, the dressing plan should aim to keep the wound dry until assessed by a multidisciplinary team.
Six average quality studies examined advanced moist wound dressings: Aquacel (hydrofibre), Fibrocol
(collagen-alginate), Polymem (starch co-polymer) and Algosteril/Sorbsan (calcium alginate) and
compared them to debridement plus gauze conventional dressings (dry, saline and greasy). Advanced
moist wound dressings did not improve ulcer healing when compared to standard wound care. No
trials comparing silver or other topical antimicrobial dressings to conventional dressings were found.
EO 9
There is insufficient evidence to demonstrate the superiority of any one
EO
wound dressing over another in management of ulcers. This means that
the dressing plan will need to be tailored to the specific characteristics of
the wound. In non-ischaemic ulcers, create a moist wound environment.
In ischaemic ulcers maintain a dry wound environment using a dry, nonadherent dressing, until the wound has been reviewed by someone with
experience in peripheral arterial disease.
Pressure reduction, redistribution of pressure or offloading of the wound
An important reason for failure of an ulcer to heal is continued trauma to the bed of the wound. This
generally occurs because the foot is insensate and the individual continues to bear weight through the
wound. The wound can however be protected by using an offloading device to reduce the pressure
through it. A number of offloading devices are currently available for use. These include total contact
casts, removable prefabricated devices, e.g. Controlled Ankle Movement (CAM) walkers, half shoes
and therapeutic shoes.
Two average quality trials examined the effectiveness of pressure reduction or wound offloading in
people with plantar foot ulcers. One trial compared total contact cast offloading10 and the other felt
foam offloading to standard wound care.81 Total contact casts increased the number of ulcers healed,
reduced healing time and reduced amputation rates. Felt foam dressing/padding and half shoe
reduced ulcer size and healing time. Pooling the effects of these offloading interventions indicated a
significant reduction in the time to ulcer healing.
Two average quality trials compared total contact casts with other prefabricated offloading devices
rendered irremovable for the treatment of plantar foot ulcers.82,83 No significant differences in the
26
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
proportion of ulcers healed or time to ulcer healing were reported. Three average quality controlled
trials and one average quality prospective non-randomised study compared irremovable devices
with removable devices for the treatment of plantar foot ulcers. The irremovable devices increased
the number of ulcers healed and reduced ulcer healing time. However, it was noted that peri-wound
maceration was also increased with the irremovable devices.84
EBR 7
Pressure reduction, otherwise referred to as redistribution of pressure or Grade B
offloading, is required to optimise the healing of plantar foot ulcers.10
EBR 8
Offloading of the wound can be achieved with the use of a total contact
cast or other device rendered irremovable.10
EO 10
Other removable offloading devices may be considered in particular
EO
settings (e.g. wounds that require more regular debridement and dressing
changes) or where patient factors (e.g. significant risk of falls) do not
allow the use of an irremovable device.
Grade B
Types of care
Multi-disciplinary care of diabetes-related foot complications
Best-practice management of diabetes-related foot ulceration requires coordinated and expert multidisciplinary input in both the inpatient and outpatient settings. Multi-disciplinary teams consist of
medical, surgical, nursing, podiatry and allied health professionals – with the appropriate skills and
knowledge needed to manage this group of individuals. Some multi-disciplinary teams also include
an infectious disease specialist or microbiologist. The integrated approach acknowledges that no
one specialist possesses all the abilities and knowledge to manage the patient. In Australia, there
is no agreed definition for the composition of a Multi-Disciplinary Foot Care Team. The Scottish
Intercollegiate Guideline Network (SIGN) definition is used as a reference point (see Box 5 for
definition and explanation).
Box 5
Definition of Multi-Disciplinary Foot Care Team/Service
Multi-Disciplinary Foot Care Team/Service
Based on the advice of the Scottish Intercollegiate Guidelines Network (SIGN)85
and from other studies, a multi-disciplinary foot (MDF) care team/service would
ideally include:
•
Podiatrist
•
Diabetes physician
•
Diabetes nurse specialist
•
Vascular surgeon
•
Orthopaedic surgeon
•
Radiologist
•
Wound care nurse
•
Footwear technician
MDF care teams/services provide evidence-based staged management of
diabetic foot ulcers is implemented via detailed algorithms according to guidelines
for both assessment and treatment, which provide standardised treatment
protocols for each risk category. The various components of the team do not
need to operate at a single location.
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
27
Box 6
Team Skills for Reducing Amputation Rates
Seven Essential Skills for Targeted Limb Salvage
Fitzgerald et al have identified seven essential skills that necessarily enable
a limb salvage team to appropriately manage the most common presenting
problems in patients with diabetes, including vasculopathy, infection, and
deformity.86 These include:
(1) perform hemodynamic and anatomic vascular assessment with
revascularization, as necessary;
(2) perform neurologic workup;
(3) perform site-appropriate culture technique;
(4) perform wound assessment and staging/grading of infection and ischemia;
(5) perform site-specific bedside and intraoperative incision and debridement;
(6) initiate and modify culture-specific and patient-appropriate antibiotic therapy;
and
(7) perform appropriate postoperative monitoring to reduce risk of reulceration
and infection.
Three large, average quality studies (controlled or cohort) compared the multi-disciplinary staged
care of foot ulcers to standard care.11-14 The multi-disciplinary care approach was associated with
substantially reduced amputation rates, foot related hospitalisation and length of hospital stay.
One randomised trial of average quality examined the effectiveness of digital imaging (digital
photographs of wounds and measurements) and a remote expert consultant compared to digital
imaging and standard care by the local physician in the treatment of lower extremity ulcers. Remote
expert advice with digital imaging improved ulcer healing rates (reduction in ulcer size per week) and
reduced amputation rates.
EBR 9
People with diabetes-related foot ulceration are best managed by a
multi-disciplinary foot care team11-14
Grade C
EO 11
The following factors should always precipitate referral to a multidisciplinary foot care team:
EO
•
deep ulcers (probe to tendon, joint or bone)
•
ulcers not reducing in size after 4 weeks despite appropriate treatment
•
the absence of foot pulses
•
ascending cellulitis and
•
suspected Charcot’s neuroarthropathy (e.g. unilateral, red, hot,
swollen, possibly aching foot)
If access to a multi-disciplinary foot care team is limited, foot ulceration or
foot complications other than those above should be managed by a GP
together with a podiatrist and/or wound care nurse.
EBR 10
28
Remote expert consultation with digital imaging should be made
available to people with diabetic foot ulceration living in remote areas
who are unable to attend a multi-disciplinary foot care team/service
for management.15
Grade C
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
Systemic drug interventions
Antimicrobials for non-infected ulcers
The need for antimicrobial therapy in the management of foot ulcers will depend on the presence or
absence of clinical evidence of infection.
Infected ulcers should be treated with antimicrobial therapy according to published antibiotic
guidelines†.87 In the setting of clinical infection it is appropriate for cultures to be collected for
identification of microbiological organism/s and antibiotic sensitivities. There is no role in culturing
clinically uninfected ulcers as colonising organisms will always be detected. Similarly, cultures should
not be taken to determine the need for antibiotics. The need for antibiotics should be determined on
clinical grounds. The most appropriate tissue samples for microbiological evaluation are either deep
tissue swabs after debridement or tissue/bone biopsies.54
There is no consistent evidence that the use of an antimicrobial is indicated in the management of
non-infected ulceration. One good quality trial88 and one average quality cohort study89 assessed the
effects of antibiotics compared to placebo in addition to standard care. No significant effects on ulcer
healing or ulcer size were reported.
Lipid modifying agents
One good quality trial evaluated the use of fenofibrate for reducing amputations (a pre-specified
tertiary outcome) in people with type 2 diabetes.90 After a median follow up of 5 years, fenofibrate
significantly reduced all amputations. This was primarily due to a significant reduction in minor
amputations in people without large vessel disease. No significant effects on major or minor
amputations in people with large vessel disease were observed.
Although this study suggests that fenofibrate may have a promising role in preventing minor
amputation due to microvascular disease in people with type 2 diabetes, the expert panel considered
that the data were insufficient to make a recommendation at this time, because of the inconsistency
of the results (benefits only seen in people free of large vessel disease). Further trials examining a
broader range of pre-specified foot outcomes (including amputation and ulcer healing) are required to
confirm any likely beneficial effects and the types of patients likely to benefit.
Agents for the improvement of microvascular blood flow and improving immune function
Studies have been conducted on the following therapies, but there was insufficient evidence to make a
recommendation for any of them:
• Angipars -Herbal extract
• Low molecular weight heparin
• Illoprost
• Ketanserin
• Pentoxyfyline
• Pycnogenol
• Tinospora cordifolia
† The antibiotic guideline referenced here is commonly referred to by clinicians in their everyday practice however it does not
meet the criteria set by NHMRC for an evidence based guideline.
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Nutritional supplements
People with foot complications may experience a number of nutritional deficiencies.
Two small studies examined the effect of herbal91 or nutritional supplements92 on ulcer healing or
amputation in patients with foot ulceration. No significant effects were demonstrated. It therefore
remains unknown whether any treatment for nutritional deficiencies improves ulcer healing or reduces
amputation rates.
D2 Treatment of Diabetic Foot Ulceration in Specialist Settings
Topical negative pressure therapy
Topical negative pressure therapy is non-invasive and creates a localised, controlled sub-atmospheric
pressure environment that promotes faster wound healing.17 The exact mechanism for enhancing
wound healing is unclear but is thought to involve increasing local blood flow, encouraging the
formation of granulation tissue, decreasing bacterial colonisation, enhancing cell migration across the
wound bed, and reducing oedema.19
Six studies (two good quality17,22 and four average quality16,18-21) examined the effectiveness of topical
negative pressure therapy in addition to standard wound care (including aggressive debridement
and dressings) compared to standard care alone in treating diabetic foot ulceration. Topical negative
pressure therapy significantly reduced ulcer size, improved the number of ulcers healed and reduced
the need for minor amputation.
EBR 11
Topical negative pressure therapy may be considered for foot
ulcers in specialist centres, as part of a comprehensive wound
management program.16-22
Grade B
Hyperbaric oxygen therapy
Hyperbaric oxygen therapy (HBOT) involves the administration of oxygen at 2-3 times the sea-level
atmospheric pressure and produces tissue oxygen levels that are ten-fold greater than normal and
sufficient to meet resting cellular oxygen requirements independent of circulating haemoglobin.
This requires the patient to be confined within an airtight vessel and given 100 percent oxygen for
respiration. Sessions usually take between 45 and 120 minutes and are administered once or twice
daily depending on the setting.30
One good quality systematic review (of four average quality studies) examined the effectiveness of
HBOT compared to standard care for the treatment of non-healing diabetic foot ulceration (present for
at least six weeks).30 HBOT healed ulcers faster and reduced the risk of major amputation.
A cost utility analysis of adjunctive HBOT in the treatment of diabetic ulcers suggests that HBOT
is cost effective if used long-term.57 However this was based on US data and further research is
warranted before adopting adjunctive long-term HBOT.
EBR 12
Hyperbaric oxygen therapy may be considered for foot
ulcers in specialist centres, as part of a comprehensive wound
management program.23-30
Grade B
Larval therapy
In addition to local sharp debridement of wounds, sterile larvae may be applied to assist with
debridement. Three studies (one controlled32 and two observational studies of average quality31,33)
30
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of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
compared the effect of sterile larval therapy with standard wound care or surgical debridement. One
study reported reduced ulcer healing time and reduced amputations,31 one reported greater reduction
in ulcer size but no effect on ulcer healing time or amputation33 and one reported reduced hospital stay
but no effect on the number of ulcers healed or amputation.32
EBR 13
Larval therapy may be considered for foot ulcers in specialist centres, as Grade C
part of a comprehensive wound management program.31-33
Skin replacement therapies
Skin/epidermal grafting or application of bioengineered skin equivalents to a clean wound may
accelerate wound healing where there is adequate limb perfusion. Skin equivalents comprise cultured
sheets of living fibroblast or fibroblast and keratinocyte cells combined with matrix proteins, cytokines
and growth factors.
Two studies investigated the use of skin grafting (split-skin grafting and grafting epidermal sheets
from suction blisters); one trial used meshed skin grafting; two trials used cultured keratinocytes,
one with autologous cells and the other with allogenic cells; and one controlled study used cultured
allogenic fibroblasts.
Skin grafting improved ulcer healing time, reduced the risk of amputation and reduced the length of
hospital stay in patients with chronic foot ulcers.93 Meshed skin grafting appeared equivalent to split
skin grafting.44
One systematic review and nine trials examined the use of cultured skin equivalents; three trials used
acellular dermal tissue matrixes; and one trial compared a cultured skin equivalent compared to an
acellular dermal tissue matrix. Cultured skin equivalents combined with standard wound care improved
the number of ulcers healed in patients with chronic foot ulcers.34-43
A systematic economic evaluation58 of some growth factors and tissue-engineered artificial skin
products (all from the United States, Canada and Europe except for one Australian study) found a
favourable cost effectiveness ratio in patients with chronic wounds. The review concluded that despite
their high initial costs, tissue-engineered wound care products were cost effective or even cost saving
if their use was restricted to chronic, non-healing ulcers.
EBR 14
Skin replacement therapies
•
Cultured skin equivalents34-43
Grade B
•
Skin grafting44
Grade D
may be considered for foot ulcers in specialist centres, as part of a
comprehensive wound management program.
Heat or electrical stimulation therapy
The use of heat or electrical stimulation therapy in the healing of foot ulcers is an emerging field.
Three small, average quality trials examined application of a warmed, wound chamber after standard
wound debridement and cleansing, and found it to be more effective in healing foot ulcers than
standard wound care alone. Increased skin maceration was however reported.94-96 One small, average
quality trial examined local heat application with an infrared lamp or global heat in a warmed room in
addition to electrical stimulation and standard wound care. Increased ulcer healing was demonstrated
compared to standard wound care alone.97 Three trials examined electric stimulation in addition to
standard wound care.98-100 All studies were underpowered. No significant effects were demonstrated.
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Larger trials are required to confirm any likely beneficial effects and determine the types of ulcers that
may benefit from these therapies.
Growth factors
Gel-based topical or parenteral recombinant growth factors have been investigated for their potential
role in the treatment of chronic non-healing foot ulcers.
Twenty-two studies examined the effects of human growth factors in various forms or blood products
including recombinant human epidermal growth factor (rhEGF), recombinant human platelet-derived
growth factor (rhPDGF), recombinant human granulocyte-colony stimulating factor (rhG-CSF),
recombinant human vascular endothelial growth factor (rh VEGF), platelet rich plasma gel/releasate,
recombinant human transforming growth factor β2 (rhTGF) and basic fibroblast growth factor (bFGF).
Recombinant human epidermal growth factor and human platelet derived growth factor have shown
the greatest promise for improving ulcer healing but further studies are necessary. However the
findings may not be generally applicable, due to lack of availability of these products in Australia and
high cost.
Box 7 Diagnosis and Treatment of Osteomyelitis
The diagnosis and treatment of osteomyelitis was not within the scope of the revision of
the guideline. The guideline developers have recommended that a full systematic review
of the area be done as a matter of urgency so evidence-based clinical advice can be
provided. In the absence of any current evidence-based guideline, clinicians may refer to
the International Working Group on the Diabetic Foot (IWGDF) advice on diagnosis and
management of osteomyelitis.101
The recommendations on diagnosis are based on clinical opinion, however the guidance on the
management of osteomyelitis in the diabetic foot is evidence-based (from a systematic review).
In summary, the IWGDF concluded that there was no evidence that surgical debridement of
the infected bone is routinely necessary. Despite the lack of evidence, however, many experts
feel that arrest of bone infection is facilitated by appropriate debridement of necrotic bone.
Culture and sensitivity of isolates from bone biopsy may assist in selecting properly targeted
antibiotic regimens, but empirical regimens should include agents active against staphylococci,
administered either intravenously or orally (with a highly bioavailable agent). There are no data
to support the superiority of any particular route of delivery of systemic antibiotics or to inform the
optimal duration of antibiotic therapy. No available evidence supports the use of any adjunctive
therapies, such as hyperbaric oxygen, granulocyte-colony stimulating factor or larvae.
The IWGDF urged caution before the conclusions that were drawn in this review were
extrapolated into practice due to the weakness of the available evidence. The quality of
published work is poor, with few controlled studies, unclear reporting and small or heterogeneous
populations. The lack of standardization of diagnostic criteria and of consensus on the choice of
outcome measures pose particular difficulties.
The IWGDF counselled that decisions concerning clinical care should be based on individual
circumstances, taking into account the needs and desires of each patient, local resources,
expertise and trends in antimicrobial resistance. While they found no evidence of differences in
the effectiveness of various treatment strategies, this may not mean that such differences do not
exist, and the important differences in both effectiveness and cost effectiveness may yet emerge
from adequately powered studies that use appropriate definitions and outcome measures.
32
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of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
D3 Monitoring of Response to Treatment and Prevention of Ulcer Recurrence
When monitoring the response of an ulcer to treatment, it is important to review the characteristics
of the ulcer and any vascular or infective complications. Further damage can occur in people with
neuropathy due to unrecognised trauma.
Ulcer evaluation should include regular documentation of the wound location, size, shape, depth,
wound bed, peri-wound tissue, wound edge, odour and exudate quantity, colour and viscosity.
The documentation system used should allow comparison of ulcer characteristics over time to
determine progress.102
Signs of infection, such as the presence of erythema, increasing heat, swelling, odour, or purulent
discharge, should be documented and aerobic and anaerobic cultures performed. Superficial swabs
are likely to identify colonising organisms and may not identify the relevant infecting organism/s.
Appropriate samples include post debridement swabs or tissue samples. A sterile probe is useful in
assessing the presence of sinus tracts and determining whether a wound extends to a tendon, joint,
or bone. Any wound extending to tendon, joint or bone will require further assessment with imaging to
investigate for osteomyelitis and deep abscess.103
Techniques to assess ulcer size include: direct measurement with a disposable ruler, tracing the ulcer
edge onto a clear film or wound tracing grid (which can be stored in the patient record or transferred
onto graph paper) or photography including a scale strip to allow an estimation of the area.54 Care
should be taken to replicate patient positioning to ensure the accuracy of the results. Systems
that allow computerised calculation of ulcer area from a tracing or digital photograph may also be
considered. Photography has significantly less inter-observer variation than traditional techniques
(such as using a ruler) and has high patient satisfaction because it avoids the pain of direct contact.104
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Part E: Future Research
Most of the studies reviewed by the systematic literature review lacked statistical power to detect a
real treatment effect or suffered from other methodological weaknesses. Good quality, large-scale
studies are urgently required to inform clinical care of people with diabetes-related foot complications.
Future studies need to consider all of the following key areas of good clinical trial design: adequate
sample size, clear inclusion criteria, true randomisation, blinded outcome assessment, clear and
consistent outcome definitions, comparisons of baseline characteristics, intention-to-treat analyses,
detailed reporting of withdrawals, concomitant use of interventions and adverse effects.
Particular areas for further research include:
• Use of fenofibrate for prevention of amputation
• Prevention, assessment and management of osteomyelitis
• The form, frequency and extent of debridement needed
• The effectiveness of antibiotic therapy compared to standard wound care on ulcer healing for
management of uncomplicated foot ulceration
• Drugs for the improvement of microvascular blood flow
• Recombinant human epidermal growth factor and human platelet derived growth factor applied
outside of highly specialised unit settings
• The effect of herbal or nutritional supplements on ulcer healing or amputation
• Thermal wound therapy in addition to standard wound care
• Educational programmes for the prevention of ulcer recurrence and amputation
• Comparative assessments of wound dressings
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Part F: Implementation
Introduction
An Implementation Working Group was established to specifically consider issues for implementation
of the recommendations and advice contained in the guideline.
During the consultation period, the guideline developers invited organisations, health professionals,
other health workers and people with diabetes to explicitly comment on matters that were pertinent to
the guideline’s implementation. An on-line survey asked individuals and organisations to provide views
on whether evidence-based recommendations and expert opinions were current practice and what
they saw as the possible barriers to implementation.
Deliberations by the Implementation Working Group, the Expert Panel and the Guidelines Advisory
Committee, were combined with feedback from the consultation to identify implementation issues,
priorities and ideas for consideration by policymakers, consumer and professional organisations.
Relationship of the Guideline to Current Practice
The feedback from the consultation and the Implementation Working Group highlighted that most
of the recommendations were usual practice at least some of the time within the broad medical and
allied health community. However, on balance, nine of the fourteen evidence-based recommendations
included in the draft guideline were considered to represent a change to usual practice in primary care,
at least for some practitioners (EBR 1-5, EBR 7-10).
The guideline developers concluded that although the EBR 6 (topical hydrogel dressings) and EBR 1114 (management strategies in specialist settings) were not likely to be usual practice amongst primary
care practitioners, they were likely to be usual practice for specialist clinicians and nurses and other
health professionals working in specialist settings. It is therefore considered that they would require
limited attention in implementation:
• Topical hydrogel dressings (EBR 6)
• Negative pressure therapy (EBR 11)
• Hyperbaric oxygen (EBR 12)
• Larval therapy (EBR 13)
• Skin replacement therapies (EBR 14)
Of the 11 expert opinions included in the guideline, all appear to represent usual practice except
podiatry review (EO 6). However, where expert opinion supports evidence-based recommendations
they have been referenced in the discussion below on implementation of practices that may not
currently be usual.
An Approach to Implementation
In making suggestions for implementation of the foot complications in diabetes guideline, what is
increasingly understood is that one strategy on its own will not result in uptake of evidence-based
guidelines. An overview of systematic reviews on changing practitioner behaviour concluded that
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
35
there were some promising results from strategies such as educational outreach (for prescribing) and
reminders.105 However, they also concluded that multifaceted interventions targeting different barriers
to change are more likely to be effective than single interventions.105 It is essential that the focus
should not be entirely on practitioner behaviour and individual preferences or attitudes, but that system
issues such as resourcing, organisational behaviour and institutional approaches need to be included
in any strategy to change behaviour.106,107
It is the strong view of the guideline developers that unless there is full integration of the guideline
recommendations into the broad framework of current practice, then the guideline will fail to be
implemented. The impact of producing written material disseminated in hard copy or electronically, is
likely to be very limited. A co-ordinated, national, multifaceted, systems approach for implementation is
considered essential by the guideline developers.
Integration of the Guideline into Daily Practice
Many of the suggestions from the consultation reinforced the view that the most effective method
of implementation of evidence-based guidelines is via integration into everyday clinical practice. In
most cases this means readily available prompts and tools at the clinical interface. For most medical
practitioners, this means medical software that indicates the need for particular actions when a
patient is in front of them, or that produces reminder notices for recalling the patient for monitoring,
assessment or management activities.
Electronic decision support tools are available and in current use for some practitioners. They do,
however, remain incomplete (diabetes is not yet one of the conditions included) and not fully integrated
into the current medical software programs that are in widespread use. The use of “sidebars”, although
highly effective when used, still relies on the practitioner choosing to load the program in addition to
their usual medical records and prescribing software. This currently represents a significant barrier to
practicing evidence-based care.
Allied health professionals are currently less likely than general practitioners or medical specialists to
use electronic records software in their clinical encounters. Therefore other means of delivering the
recommendations on assessment and care for foot complications in people with diabetes is imperative
to explore with their professional representative bodies.
Aboriginal Community Controlled Health Services currently have access to electronic clinical medical
record tools and can increasingly integrate guidelines into their activities through organisational policy
and procedures. Encouragement to implement the recommendations of the foot complications in
diabetes guidelines will be important. Awareness of the revised guideline amongst the network of
Aboriginal Community Controlled Health Organisations would facilitate the uptake into practice.
A solution to the current impasse on integration of decision support tools into medical software is
needed urgently.
Access and Resourcing
While access to timely advice at the coalface of clinical care is important, access to health services
and care in general, and specialist services in particular, for people with high risk feet and those with
current complications is equally a high priority in terms of this guideline.
The workforce issues are particularly relevant here, in terms of the recruitment, skills and training of
nurses, aboriginal health workers and podiatrists to undertake many of the recommended practices in
the guideline. Increased availability of practice nurses in GP clinics was supported. It may be possible
36
National Evidence-Based Guideline for the Prevention Identification and Management
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for nurses to do some of the assessment and monitoring work that cannot be accommodated in the
timeframe of the usual GP consultation.
A very practical approach to resourcing and access especially for rural or remote areas may be the
provision of kits that contain all the necessary equipment for foot examination (e.g. vibration fork,
sterile stick for pinprick sensation or monofilament) and associated instruction materials. The provision
of such practical resources to Aboriginal Health Workers and Aboriginal Community Controlled Health
Services for example may be a small cost; however the support may be enough to see greater
implementation of a key recommendation in a high risk group.
The strong evidence to support the intervention of multi-disciplinary teams in cases where people
have high risk or current complications should encourage both professional bodies and governments
at the State/Territory and Commonwealth level to ensure that there is access to such teams in each
jurisdiction. The avoidance of amputation, disability and/or loss of mobility for people with diabetes
and foot complications is possible if access is available, either close by, or by remote consultation
supported by digital imaging.
Consideration of policy development and funding of multi-disciplinary foot clinics for people with
diabetes at high risk of foot complication or with non-healing ulcers or Charcot’s neuroarthropathy is
a high priority. The guideline developers consider that at a minimum, all people with diabetes should
have reasonable access to a high-risk foot clinic that is adequately funded to cope with demand, and
with the facilities to deliver remote support to regional and remote centres via digital imaging.
Awareness, Education and Training
As expected, there was a call from those who responded to the consultation for more training,
education and general awareness to be put in place for this guideline. This is the case for practitioners
as well as people with diabetes. There is limited evidence to show that education activities increase
uptake of guidelines, especially when done in isolation from other more system approaches. However
there could be positive encouragement by professional bodies to make their members aware of
the revised guideline via notices in journals and newsletters, on websites and via any other means
possible such as conferences. Educational and skill development programs could be developed and
conducted as widely as possible by professional bodies.
Training and skill development of allied health workers in assessment of risk, wound debridement,
appropriate use of dressings for ulcers, and appropriate implementation of pressure reduction of
wounds were particularly raised by many respondents.
For people with diabetes, awareness of the self-care activities they could be undertaking as well as the
expectations they should have of their health care providers and the health system generally would
be useful in assisting with implementation of the guideline. Vehicles such as the NDSS and Diabetes
Australia (and its State counterparts) are obvious mechanisms for disseminating the information
about evidence-based assessment, prevention and management of foot complications in people
with diabetes.
National Evidence-Based Guideline for the Prevention Identification and Management
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37
Part G: Related International Guidelines
and Resources
A number of international guidelines exist in this area that may assist clinicians in the management
of foot-related complications from diabetes. This guideline is based upon more recent evidence.
The guideline developers are confident that the recommendations developed for this guideline
are consistent with international guidelines. The minor variations are considered to be justified by
the evidence.
International Working Group on the Diabetic Foot
Practical guidelines on the management and prevention of the diabetic foot (Based upon
the International Consensus on the Diabetic Foot) (2007). http://www.iwgdf.org/index.
php?option=com_content&task=view&id=27&Itemid=29
These guidelines are based on both evidence and consensus, and cover all aspects of prevention and
management, including a section on management of osteomyelitis.
National Institute for Clinical Excellence (NICE) - UK
Type 2 diabetes: prevention and management of foot problems http://guidance.nice.org.uk/
This is a clinical guideline on the inpatient management of diabetic foot problems.
Diabetic Foot Disorders: A Clinical Practice Guideline (US)
This guideline was developed by the Clinical Practice Guideline Diabetes Panel of the American
College of Foot and Ankle Surgeons. See J Foot Ankle Surg. 2006 Sep-Oct; 45(5 Suppl):S1-66.
This guideline is a very comprehensive and detailed set of advice about all aspects of foot risk,
assessment, prevention, pathology, ulcer evaluation and treatment, advanced wound care, infections,
Charcot and surgical management.
Management of Diabetes - A national clinical guideline – Management of Diabetic Foot
Disease (Scotland)
This guideline covers all aspects of foot complications from diabetes. http://sign.ac.uk/guidelines/
fulltext/116/index.html
Comprehensive foot examination and risk assessment: a report of the task force of the foot
care interest group of the American Diabetes Association
This guideline covers risk assessment in some detail. It is also endorsed by the American Association
of Clinical Endocrinologists. See Boulton AJ, Armstrong DG, Albert SF, et al. Comprehensive Foot
Examination and Risk Assessment. Diabetes Care. Aug 2008;31(8):1679-1685.
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Appendix 1: Grading Foot Ulcer
Severity – Additional Tools
Wagner wound grade79
Grade
Clinical assessment
1
Superficial wound
2
Deep wound involving tendons and capsules but not bone
3
Bony involvement
4
Localised gangrene
5
Generalised gangrene
DEPA scoring system108
DEPA score
Score
1
Depth of the ulcer
Extent of bacterial
2
3
Skin
Soft tissue
Bone
Contamination
Infection
Necrotising infectiona
Granulatingb
Inflammatoryc
Nonhealingd
Neuropathy
Bone deformity
Ischaemiae
colonisation
Phase of ulcer
Associated etiology
a
b
c
d
e
Infected ulcer with surrounding cellulitis or fasciitis;
evidence of granulation tissue formation;
hyperaemic ulcer with no granulation tissue < 2 weeks duration;
nongranulating ulcer > 2 weeks duration;
clinical signs and symptoms of chronic lower-limb ischaemia.
Grading of ulcers based on DEPA score
Grade of ulcer
DEPA score
Low
<6
Moderate
7–9
High
10–12 or ulcer in association with wet gangrene
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S(AD)SAD system3
Grading of ulcers by S(AD)SAD system
Grade
Area
Deep
Sepsis
Arteriopathy
Denervation
0
Skin intact
Skin intact
–
Pedal pulses
present
Intact
1
Lesion < 1cm2
Superficial
(skin and
subcutaneous
tissue)
No infected
lesions
Pedal pulses
reduced or one
missing
Reduced
2
Lesion 1–3cm2
Lesion
penetrating
to tendon,
periosteum and
joint capsule
Cellulitisassociated
lesions
Absence of both Absent
pedal pulses
3
Lesion > 3cm2
Lesion in bones
or joint space
Lesions with
osteomyelitis
Gangrene
Charcot joint
Curative Health Services classification109,110
Curative Health Center classification of foot ulcers
Grade
40
Criteria
1
Partial thickness involving only dermis and epidermis
2
Full thickness and subcutaneous tissues
3
Grade 2 plus exposed tendons, ligament, and/or joint
4
Grade 3 plus abscess and/or osteomyelitis
5
Grade 3 plus necrotic tissue in wound
6
Grade 3 plus gangrene in the wound and surrounding tissue
National Evidence-Based Guideline for the Prevention Identification and Management
of Foot Complications in Diabetes (part of the guidelines on Type 2 Diabetes) 2011
International Working Group on the Diabetic Foot
Criteria for wound classification
Perfusion
Depth of wound
Infection
Sensation
Grade 1
No symptoms or signs
of ischaemia, palpable
pedal pulses, 0.9 < ABI
< 1.1
Grade 1
Superficial ulcers
not penetrating any
structure below the
dermis
Grade 1
No signs or symptoms
of infection
Grade 1
No loss of sensation of
the affected foot
Grade 2
Signs and symptoms
of intermittent
claudication, or
ABI <0.9 with ankle
pressure >50 mmHg
Grade 2
Deep ulcers
penetrating down
to subcutaneous
structures, fascia,
muscles, and tendons.
Grade 2
Infection involving skin
and subcutaneous
tissues without
systemic signs: Local
swelling and induration;
erythaema >0.5–2 cm
around ulcer; local
tenderness or pain;
local warmth; purulent
discharge
Grade 2
No pressure
sensation with a 10g
monofilament on two
or three sites on the
plantar side of the foot.
No vibration sense with
a 128 Hz tuning fork on
both sides of the hallux.
Grade 3
Critical limb ischaemia
defined by systolic
ankle pressure
<50mmHg
Grade 3
Deep ulcers
penetrating down to the
bone and/or joint.
Grade 3
Erythaema >2cm Deep
abscess; osteomyelitis;
septic arthritis and
fasciitis.
Grade 4
Any foot infection
associated with
systemic inflammatory
response syndrome.
Temperature >38°C or
<36°C; heart rate >90
beats/min; respiratory
rate >20 breaths/min;
total white cell count
>12,000 or <4000/cm
ABI = ankle-brachial index also known as ankle-brachial pressure index (ABPI)
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Appendix 2: Charcot’s
Neuroarthropathy
What is Charcot’s neuroarthropathy?
Charcot’s neuroarthropathy (hereafter referred to as CNA) is a non-infectious, degenerative disease
of the bones and joints, particularly weight-bearing joints such as the foot and ankle. In developed
countries diabetic neuropathy is the most common cause. It is characterised by joint dislocation,
fractures and deformities and in extreme cases may significantly disrupt the bony architecture of the
affected joint.
What are the causes of CNA?
CNA is caused by sensory or autonomic neuropathy. There are several theories proposed to explain
its aetiology.
• Neurotraumatic theory: This proposes that peripheral neuropathy impairs proprioception causing
overuse injuries of insensate joints, either from repetitive microtrauma or a single traumatic event.
The loss of protective mechanisms results in the initial injury or injuries.
• Neurovascular theory: This suggests that autonomic dysfunction leads to increased blood flow
(via arterio-venous shunting), an imbalance of bone destruction and synthesis, and subsequent
bone resorption and weakening (osteopenia)
• Involvement of inflammatory cytokines (e.g. tumour necrosis factor-α and interleukin-1), which
result in the stimulation of osteoclast formation.
Who gets CNA?
CNA typically manifests in patients with long-standing diabetes and peripheral neuropathy.111
The annual incidence of CNA among those with diabetes has been estimated to be between 0.1% and
1.4%. Over recent years the incidence and/or diagnosis of CNA has been reported to be increasing.112
What are the symptoms and signs of CNA?
The commonest symptoms of CNA are redness, swelling, changing foot shape and new onset of pain
or discomfort. About half of patients with CNA experience some pain, however the severity of the pain
may be less than clinical signs and symptoms would seem to indicate. The pain may be described as
a “deep” aching pain.
Specific clinical signs indicating the presence of CNA include:
• In all cases - neuropathy and pounding pulses
• Early cases - may only have erythema and swelling
• Advanced cases - more swelling, effusions and change in foot shape
• Unilateral swelling and joint deformity varies within a wide range depending on the stage of
the disease
• Increase in local skin temperature is generally about 3oC higher in the affected extremity
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• There may be absence of sweating (indicating neuropathy) and an insensate foot
• Instability, loss of joint function and concomitant ulceration may also be evident
People in the acute stages of CNA usually have signs of inflammation in the affected area. This
inflammation is often reported as having developed over a few days. There may be no history of
a traumatic event (or at least an event that is recalled) or only a history of a very minor traumatic
event some weeks before the onset of symptoms. X-rays may appear normal early on in the course.
However, as the condition progresses there will be joint dislocation, bone and joint destruction, and
these signs will be evident on X-ray. Even if the x-ray is normal, if there is a high degree of clinical
suspicion, then proceed to an MRI.
Stages of CNA
Several classification systems have been proposed to assist in the diagnosis of CNA. The most
prevalent is the one devised by Eichenholtz in 1966,113 which has since been modified slightly
by subsequent investigators.111 The stages and associated markers of this revised classification
system are:
Stage 0
normal radiographs, loss of protective sensation, swelling and erythema, clinical
instability, (disorder may be misdiagnosed as a deep infection or cellulitis)
Stage l
(fragmentation, dissolution or development stage) – osteopenia, periarticular
fragmentation, fracture, subluxation of joints, warm oedematous foot, laxity of ligaments
Stage II
(coalescence stage) – healing phase, less oedema and warmth, absorption of debris,
fusion of bony fragments, early sclerosis
Stage III
(reconstruction or remodelling stage) – absence of inflammation, more stable but
deformed foot, osteophytes, subchondral sclerosis, narrowing of joint spaces
Distinguishing between CNA and Osteomyelitis
The symptoms and signs of CNA and osteomyelitis may be similar. In the acute stage, differentiating
CNA from osteomyelitis can be difficult. Both conditions often present as a hot, swollen, erythematous
foot with either normal or non-distinguishing changes on plain radiographs. However pedal
osteomyelitis is almost always associated with an ulcer (initiating event). In CNA, ulceration occurs
sometimes but is a secondary event.
As it is often difficult to establish the diagnosis of osteomyelitis with microbiological sampling of
affected bone, MRI has emerged as the investigative modality of choice to distinguish osteomyelitis
from acute CNA.54 Diagnosis of osteomyelitis with MRI is based on identification of altered bone
marrow signal intensity (loss of normal fatty marrow signal intensity on T1-weighted images, with
oedema on T2-weighted images and enhancement on post-contrast gadolinium enhanced T1
weighted images). CNA may alter the marrow signal similarly so other radiological signs, such as
pattern and location of signal intensity, should be used to help distinguish the two processes. CNA
most commonly affects the tarsal-metatarsal and tarsal joints while osteomyelitis is almost exclusively
from contiguous infections and occurs most frequently around the fifth and first metatarso-phalangeal
joints, the first distal phalanx and the calcaneus. Associated findings in the adjacent bone, joint or soft
tissue should also be considered when making a diagnosis.
Aim of treatment
The aim of treatment of CNA is to prevent progression of the disease. Complications that may
arise from inadequate or delayed treatment include foot deformity, chronic ulceration and infection
(including osteomyelitis).
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Management
Suspected acute CNA of the foot is considered an emergency and should prompt immediate referral
to a dedicated multi-disciplinary foot care service. Early management aims to eliminate further trauma
or stress to the foot by preventing weight bearing. Offloading with a total contact cast has been shown
to protect the foot, reduce foot temperature and reduce bone activity. Offloading is widely accepted as
the most effective treatment for patients with acute CNA. Surgical intervention to fix the joint in order to
produce a stable foot and to correct deformity is required in some cases. Bisphosphonates have also
been studied for their potential to decrease bone resorption. However, further studies are required to
determine the role of these agents in the management of CNA.
Management should also consider protection of the other (non CNA-affected) foot as it will be taking
extra weight.
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Appendix 3: Foot Expert Panel
Expert Panels
The expert panels proposed the initial clinical questions to the Guidelines Advisory Committee (GAC)
to be answered by the updated guideline and provided input on the scope and format of the current
guideline. The Expert Panels provided guidance to the technical team at Adelaide Health Technology
Assessment (AHTA) regarding strategic research and reviews that may have been done in recent
times and assisted in ensuring the draft protocol for the systematic review was appropriate prior
to sign off by the GAC. During the search and review process for the systematic review, individual
experts were called upon to provide advice or interpretation of the evidence as required.
Expert Foot Panel
Membership
Personnel / Speciality
Foot complications
Australian and overseas
Professor Peter Colman (Chair) –
experts in foot complications Endocrinologist
Dr Sara Jones – Podiatry Academic
Professor Andrew Boulton* - Physician Foot
Disease Specialist
Dr Rob Fitridge – Vascular Surgeon
Dr Paul Wraight – Endocrinologist, Diabetic
Foot Unit Director
Ms Sue Templeton – Nurse Practitioner Wound
Management
Overall diabetes
care
Australian experts in clinical
care of people with type 2
diabetes
A/Professor Jonathan Shaw (Chair) Diabetologist
Professor Paul Zimmet - Diabetologist
Dr Pat Phillips - Diabetologist
Professor Tim Davis – Professor of Medicine
Dr Lynn Weekes – Quality use of Medicines
Diabetes in
Indigenous
Communities
Australian experts in care
of indigenous people with
diabetes
Dr Alex Brown (Chair)
A/Professor Ashim Sinha
* International expert
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Systematic Reviewers, Adelaide Health Technology Assessment (AHTA)
The technical report underpinning this guideline was completed by the team listed below.
• Elizabeth Buckley
• Stynke Docter
• Judy Morona
• Edith Reddin
• Vineet Juneja
• David Tamblyn
• George Mnatzaganian
• Benjamin Ellery
• Samuel Lehman
• Tracy Merlin
The report is available at: http://t2dgr.bakeridi.edu.au as is the declaration of competing interests of
every team member.
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Appendix 4: Project Executive
The key management structure associated with the project was the Project Executive. The Project
Executive consisted of representatives of the key organisations collaborating on this project: The
Baker IDI Heart and Diabetes Institute, The University of Adelaide’s Adelaide Health Technology
Assessment (AHTA), and the George Institute for Global Health.
Name
Organisation
Perspective/
Background
Role
Associate Professor
Jonathan Shaw
Baker IDI
Clinician, diabetologist,
epidemiologist
Project Leader
Professor Paul Zimmet
Baker IDI
Clinician, diabetologist,
epidemiologist
Specialist Adviser
Ms Tracy Merlin
AHTA
Specialist systematic
review methodologist,
public health
Guidelines Adviser
Oversight of systematic
review and guidelines
methodology
Ms Kathy Mott
Baker IDI
Management, primary
care policy and
practice, consumer
participation and
advocacy
Project Manager
Professor Bruce Neal
George Institute for
Global Health
Clinician, hypertension
expert, researcher
Deputy Project Leader
Dr Sophia Zoungas
George Institute for
Global Health
Clinician,
endocrinologist,
researcher
Oversight of Guideline
Writing
The competing interest of every team member can be found at: http://t2dgr.bakeridi.edu.au
National Evidence-Based Guideline for the Prevention Identification and Management
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Appendix 5: Guidelines Advisory
Committee
The Guidelines Advisory Committee (GAC) was responsible for overseeing the review and update of
the guideline, their specific role included but was not limited to:
•
Reviewing the current guideline and defining clinical questions to guide the updating process
•
Signing off on the final review protocol prior to the systematic review of the literature
•
Reviewing the draft guidelines and providing feedback prior to release for consultation
•
Assisting with consultation amongst peers and with stakeholder organisations
•
Reviewing the feedback from the stakeholder consultation, and
•
Signing off on the final guideline prior to submission to NHMRC for endorsement.
Professor Hugh Taylor was appointed as an independent chair responsible for managing and leading
the Guidelines Advisory Committee.
Nominating Organisation
Perspective/Interests
Represented
Nominee
Diabetes Australia Ltd
People with diabetes
Dr I White /
Professor G Johnson
Australian Diabetes Society
Specialist clinicians
A/Professor N W Cheung
Australian Diabetes Educators
Association
Diabetes educators and nurses
Ms C Matthews
Dietitians Association of
Australia
Dietitians and Nutritionists
Dr M Vale
Consumers’ Health Forum
People with diabetes and carers Ms H Mikolaj
Mr T Benson
Royal Australian College of
General Practitioners
General practitioners
Practice nurses
Professor M Harris
An appropriate indigenous
health organisation – Aboriginal
Health Council (SA)
Indigenous health workers
Ms S Wilson
Pharmaceutical Society of
Australia
Community and hospital
pharmacists
Dr L Bereznicki
Public Health Association of
Australia
Health promotion and
prevention
A/Professor R Colagiuri
National Heart Foundation of
Australia
Cardiovascular health
Professor J Tatoulis
National Vascular Disease
Prevention Alliance
Cardiovascular absolute risk
Dr E Lalor
Australasian Podiatry Council
Podiatrists
Mr P Lazzarini
Department of Health and
Ageing
Health policy
Ms L Cotton
The competing interest of every team member can be found at: http://t2dgr.bakeridi.edu.au
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Appendix 6: Glossary of Acronyms/
Terms
ABPI
Ankle-brachial pressure index (also referred to as ABI, Ankle-brachial index)
AIHW
Australian Institute of Health and Welfare
AusDiab Australian Diabetes, Obesity and Lifestyle Study
CNA
Charcot’s neuroarthropathy
EBR
Evidenced-based recommendation
EO
Expert Opinion
GAC
Guidelines Advisory Committee
HBOT
Hyperbaric oxygen therapy
IDF
International Diabetes Federation
IWGDF
International Working Group on the Diabetic Foot
MBS
Medicare Benefits Scheme
MDF
Multi-Disciplinary Foot (clinic/service)
MRI
Magnetic Resonance Imaging
NDS
Neuropathy Disability Score
NHMRC National Health and Medical Research Council
NVDPA
National Vascular Disease Prevention Alliance
PAD
Peripheral arterial disease (also known as peripheral vascular disease- PVD)
QALY’s
Quality adjusted life years
RCT
Randomised controlled trial
SIGN
Scottish Intercollegiate Guidelines Network
Study
Non randomised or observational study
TcPO2
Transcutaneous oxygen saturation
UT
University of Texas
VAC
Vacuum Assisted Closure
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